Biocad Expects Marketing Authorization in India for Its Rituximab Biosimilar

Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.

According to Biocad, the Indian market for rituximab exceeds $40 million annually, and total sales for rituximab products could reach $58 million over the next 5 years. The company states that, despite these impressive earnings, India has faced low availability of rituximab, and that it believes that its biosimilar’s market entry will not only spur price competition, but also result in greater patient access.

In June, the company’s rituximab biosimilar was also approved for marketing in Bolivia and Honduras, where it will be marketed under the name USMAL. The treatment is also available in 7 other countries worldwide, including Kazakhstan, Vietnam, and Sri Lanka. Biocad reports that it seeks to gain additional marketing authorizations for the drug within the year.

Dmitry Morozov, CEO of Biocad, says, “We are happy to see Acellbia, our first biosimilar drug product...receive [marketing authorization] in India, but our efforts to register more products there will continue.” The Saint Petersburg-based biotechnology company hopes to bring its second biosimilar to the Indian marketplace in the first quarter of 2018; Biocad expects to receive a marketing authorization for its trastuzumab biosimilar (Herticad), which is already supplied to countries including Syria and Sri Lanka, early next year.

Biocad’s trastuzumab biosimilar, referenced on Herceptin, was developed under a government funding initiative together with the company’s rituximab and bevacizumab biosimilars, and was first approved for marketing in Russia in 2016. At the time, the company expressed a hope that its biosimilar products would help make Russian healthcare less dependent upon foreign imports of biologic treatments. However, the company’s latest initiatives, including a substantial investment in Finland to supply drugs to the European marketplace, suggest that the booming company is not only poised to supply Russia with cost-saving biosimilar products, but also well on its way to creating competition within the global biologics market.